Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

NCT07304466 | Recruiting

• 1 other identifier: Medipol Hospital 6
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effects of somatostatin and terlipressin on lowering portal pressure in patients with portal hypertension undergoing liver transplantation, and to investigate whether there are differences in clinical outcomes between the two drugs. The study will evaluate the decrease in portal pressure from baseline following drug administration at defined time points. It will also compare the effects of these drugs on hemodynamics, bleeding, and transfusion requirements. After baseline intraoperative direct portal pressure measurement, a bolus dose of the study drug will be administered, followed by continuous intravenous infusion intraoperatively and for 24 hours postoperatively. Direct portal pressure will be measured again 5 minutes after the bolus dose, after the portal vein anastomosis, after the hepatic artery anastomosis, and, if performed after splenic artery ligation. Hemodynamic parameters will be recorded, and the drugs will be compared in terms of their intraoperative hemodynamic effects. As elevated portal pressure is associated with increased bleeding, intraoperative blood loss and transfusion needs will also be assessed between the groups. Patients will be followed for 7 days postoperatively for clinical and laboratory outcomes.

Conditions

Liver Transplantation; Portal Hypertension

Keywords

liver transplantation; portal pressure; portal hypertension; living donor liver transplantation; somatostatin; terlipressin

Outcome Measures

Primary Outcomes (1)

• Decrease in portal pressure by 20% from the baseline

  The proportion of patients achieving a ≥20% reduction in portal pressure from baseline at any of the predefined intraoperative assessment timepoints will be recorded.

  Baseline (before bolus drug administration) 5 minutes after bolus drug administration Immediately after completion of the portal vein anastomosis Immediately after completion of the hepatic artery anastomosis

Secondary Outcomes (7)

• Change in Portal Pressure (mmHg)

  Intraoperative: baseline and subsequent measurements at 5 minutes after bolus administration and immediately after completion of portal and hepatic artery anastomoses.

• Amount of bleeding (milliliters)

  Periprocedural

• Perioperative Blood Transfusion (Units)

  During the perioperative period

• Hepatic Artery Peak Systolic Flow (cm/s)

  Immediately after arterial anastomosis (intraoperative)

• Portal Vein Flow Velocity (cm/s)

  Immediately after completion of the hepatic arterial anastomosis (intraoperative)

Study Arms (2)

Group Somatostatin (SS)

ACTIVE COMPARATOR

Somatostatin will be given.

Drug: Somatostatin

Group Terlipressin (TR)

ACTIVE COMPARATOR

Terlipressin will be given.

Drug: Terlipressin

Interventions

Somatostatin DRUG

Following baseline portal pressure measurement from the portal vein (25 Gauge intracath, Bıçakçılar®) (PVP0), somatostatin (Somatex®) will be administered as a 250 mcg bolus over 2 minutes, followed by a continuous infusion at 2.5 mcg/kg/hour. Direct portal measurements will be done at the time points explained in the study description. Intraoperative ultrasound (GE Healthcare®, linear probe) will be used to record arterial and portal flow parameters. Hemodynamic data will be collected during all measurements. The study drug will be infused continuously for at least 24 hours.

Group Somatostatin (SS)

Terlipressin DRUG

Following baseline portal pressure measurement from the portal vein (25 Gauge intracath, Bıçakçılar®) (PVP0), terlipressin (Glypressin®) will be administered as a 1 mg bolus over 2 minutes, followed by a continuous infusion at 2 mcg/kg/hour. Direct portal measurements will be done at the time points explained in the study description. Intraoperative ultrasound (GE Healthcare®, linear probe) will be used to record arterial and portal flow parameters. Hemodynamic data will be collected during all measurements. The study drug will be infused continuously for at least 24 hours, and up to 5 days if portal pressure remains elevated.

Group Terlipressin (TR)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for right lobe living donor liver transplantation with clinically significant portal hypertension (esophageal varices, thrombocytopenia (\<100,000), ascites, encephalopathy; Child-Turcotte-Pugh class B-C)

You may not qualify if:

• Allergy to any of the medications to be used
• Portal vein thrombosis
• Being treated with terlipressin with a diagnosis of hepatorenal syndrome
• Portopulmonary hypertension
• Acute on chronic liver failure
• Chronic renal failure (glomerular filtration rate ≤ 30%)
• Myocardial ischemia
• Uncontrolled hypertension
• Arrhythmia
• Multiple solid organ transplantation

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Medipol Mega Hospital

Istanbul, Bagcilar, 34218, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.

  PMID: 31200638 BACKGROUND

• Li XL, Zhu XD, Xiao N, Liu XF, Xu B, Shi GM, Huang C, Shen YH, Cai JB, Zhou J, Fan J, Sun HC. A prospective study of the effect of terlipressin on portal vein pressure and clinical outcomes after hepatectomy: A pilot study. Surgery. 2020 Jun;167(6):926-932. doi: 10.1016/j.surg.2020.01.013. Epub 2020 Feb 26.

  PMID: 32113581 BACKGROUND

• Papaluca T, Gow P. Terlipressin: Current and emerging indications in chronic liver disease. J Gastroenterol Hepatol. 2018 Mar;33(3):591-598. doi: 10.1111/jgh.14009.

  PMID: 28981166 BACKGROUND

• Abraldes JG, Bosch J. Somatostatin and analogues in portal hypertension. Hepatology. 2002 Jun;35(6):1305-12. doi: 10.1053/jhep.2002.33469. No abstract available.

  PMID: 12029614 BACKGROUND

• Lizaola-Mayo B, Vargas HE. Hepatorenal Syndrome-Acute Kidney Injury in Liver Transplantation. Clin Gastroenterol Hepatol. 2023 Sep;21(10S):S20-S26. doi: 10.1016/j.cgh.2023.06.010.

  PMID: 37625863 BACKGROUND

• Iwakiri Y. Pathophysiology of portal hypertension. Clin Liver Dis. 2014 May;18(2):281-91. doi: 10.1016/j.cld.2013.12.001. Epub 2014 Feb 25.

  PMID: 24679494 BACKGROUND

• Giabicani M, Joly P, Sigaut S, Timsit C, Devauchelle P, Dondero F, Durand F, Froissant PA, Lamamri M, Payance A, Restoux A, Roux O, Thibault-Sogorb T, Valainathan SR, Lesurtel M, Rautou PE, Weiss E. Predictive role of hepatic venous pressure gradient in bleeding events among patients with cirrhosis undergoing orthotopic liver transplantation. JHEP Rep. 2024 Feb 28;6(6):101051. doi: 10.1016/j.jhepr.2024.101051. eCollection 2024 Jun.

  PMID: 38699073 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Somatostatin; Terlipressin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Oligopeptides

Study Officials

• ayşe ince

  Istanbul Medipol University Medipol Mega Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ayse ince, assist prof

CONTACT

+905366774988; drayseince@gmail.com

pelin karaaslan, prof

CONTACT

+905057657550; drpelinsesli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The surgeons performing the portal pressure measurements and the participants will be blinded to group allocation. The study drugs will be prepared and labeled by an independent anesthesiologist/pharmacist not involved in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 26, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)